BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO 2515 NAV VARIABLE CATHETER

    MDR report key: 2869998 · Received December 12, 2012

    Report

    Report Number
    9673241-2012-00358
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 19, 2012
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DRF
    PMA / PMN Number
    K081258
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT CARTO 3 SYSTEM WAS USED FOR A PULMONARY VEIN ISOLATION. THE PHYSICIAN PLUGGED IN THE NAVISTAR THERMOCOOL CATHETER TO MARK THE HIS LOCATION DURING TRANSSEPTAL. AFTER THE 1ST TRANSSEPTAL, THE LASSO NAV CATHETER WAS OPENED AND PLUGGED INTO THE PIU. AS SOON AS THIS WAS DONE, THERE WAS SIGNIFICANT NOISE ON BOTH THE INTRACARDIAC AND BODY SURFACE SIGNALS ON BOTH THE CARDIOLAB AND CARTO SYSTEM. THE LASSO NAV CATHETER WAS THEN REPLACED AND ALL NOISE AND ERRORS DISAPPEARED. THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND IT WAS FOUND IN NORMAL CONDITIONS. THEN PER THE EVENT, CATHETER WAS TESTED FOR EEPROM, CARTO, 4 KHZ AND CALIBRATION FUNCTIONALITY; IT WAS ALSO TESTED FOR ELECTRICAL RESISTANCE AND CURRENT LEAKAGE. THE CATHETER PASSED THESE TESTS. NO ERRORS WERE DISPLAYED ON THE SYSTEM. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS FAILURE MODE. DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CARTO 3 SYSTEM WAS USED FOR A PULMONARY VEIN ISOLATION. THE PHYSICIAN PLUGGED IN THE NAVISTAR THERMOCOOL CATHETER TO MARK THE HIS LOCATION DURING TRANSSEPTAL. AFTER THE 1ST TRANSSEPTAL, THE LASSO NAV CATHETER WAS OPENED AND PLUGGED INTO THE PIU. AS SOON AS THIS WAS DONE, THERE WAS SIGNIFICANT NOISE ON BOTH THE INTRACARDIAC AND BODY SURFACE SIGNALS ON BOTH THE CARDIOLAB AND CARTO SYSTEM. CARTO 3 SHOWED 2 ERRORS: ERROR 21 (FAILURE IN ECG 3 CARD - PIU BUILT-IN TEST FAILED) AND ERROR 25 (FAILURE IN RX CARD - PIU BUILT IN TEST FAILED). THE CARTO 3 SYSTEM WAS POWER CYCLED AND THE LASSO NAV CABLE WAS REPLACED. HOWEVER, THE ERRORS AND RED INDICATORS LIGHTS STILL SHOWED ON THE BACK OF THE PIU. THE LASSO NAV CATHETER WAS THEN REPLACED AND ALL NOISE AND ERRORS DISAPPEARED. THE RED INDICATOR LIGHTS ON THE BACK OF THE PIU WERE ALSO RETURNED TO GREEN. THE CASE PROCEEDED WITHOUT FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASSO 2515 NAV VARIABLE CATHETER ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1290-01-S 15635889L

    Patients

    Seq Age Sex Outcome Treatment
    1